IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00191506032692, Batch Numbers: 33744276, 33744277, 33744278, 33744600, 33931638, 33931639, 33931900, 33980480, 33980481, 33980482, 33989380, 33989381, 33989382, 34063066, 34063067, 34063068, 34063069, 34063070, 34084080, 34084081, 34084084, 34094111, 34094112, 34110333, 34110334, 34110335, 34110336, 34110337, 34168777, 34168778, 34204925, 34204926, 34204927, 34295709.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Product Codes/Lot Numbers:
GTIN 00191506032692, Batch Numbers: 33744276, 33744277, 33744278, 33744600, 33931638, 33931639, 33931900, 33980480, 33980481, 33980482, 33989380, 33989381, 33989382, 34063066, 34063067, 34063068, 34063069, 34063070, 34084080, 34084081, 34084084, 34094111, 34094112, 34110333, 34110334, 34110335, 34110336, 34110337, 34168777, 34168778, 34204925, 34204926, 34204927, 34295709.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1688-2025
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